Knotless suture system

ABSTRACT

A knotless suture system formed from two lengths of suture joined at a suture junction point, with at least four suture limbs extending from the suture junction. The knotless suture system provides the ability to construct a suture bridge for soft tissue repair and fixation across a medial and lateral row bone fixation anchor configuration while passing the suture system in a simplified method of suture management.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Application No.61/417,081 filed Nov. 24, 2010, the entirety of which is incorporatedherein by reference in its entirety.

BACKGROUND

Rotator cuff surgery continues to evolve. Initially surgery wasperformed using transosseous techniques. The advent of anchors enabledthe procedures to be performed arthroscopically. Prior art approachestypically use either single or double row repair techniques with knottedsutures. The sutures act to hold the tendon next to the bone during thehealing process.

The evolution has gone from single row to double row repairs. However,these constructs require surgeons to know how to tie complicated knotswhich are technically challenging. The suture knots in the tissue can bebulky and create a painful impingement of the tendon on the bone. Thisis because the knots end up on top of the cuff, in the sub-acromialspace, and have the opportunity to rub on the acromion as the arm israised. Because non-absorbable suture materials are used for these typesof repairs, the suture and associated knots are not absorbed into thebody, and hence provide a constant, painful reminder of their presence.Furthermore, there are issues surrounding the use of tying knots whichinclude knot security and loop security. There is also the potential forthese knots to increase the chance of tissue reaction. Another concernis the potential for knots to create a “clicking” sound associated withpatient irritation.

Better instruments and improved anchor designs facilitated knotlesssingle row configurations. Next, double row transosseous equivalentrepairs were developed. Many of these techniques still requirecomplicated knots. Again, the problems previously described with knotsare still issues of this technique. One potential advantage of thistechnique is that there is independent medial row fixation. Anotherderivative of this repair construct is a knotless “bridge” technique.While this technique eliminates the need to tie knots, the medial andlateral row fixation is dependent on one another. In other words, if thelateral row fails then so does the corresponding medial row. Anarthroscopic technique that enables a truly knotless double rowtransosseous repair with application of medial pressure is desirable. Animproved suture system and methods of using such a suture system wouldaddress the concerns previously described and would also allow forsurgeons of various skill levels to perform the techniquearthroscopically and without the need for knot tying.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 illustrates a side view of a traditional knotted double rowrepair;

FIG. 2 illustrates a top view of a traditional knotted double rowrepair;

FIG. 3 illustrates a side view of a present version knotless double rowrepair;

FIG. 4 illustrates a side view of a present version knotless double rowrepair;

FIG. 5A illustrates a view of an interwoven suture configuration inaccordance with at least some embodiments;

FIG. 5B illustrates a view of an interwoven suture configuration inaccordance with at least some embodiments;

FIG. 6 illustrates a side view of an interwoven suture configurationadjacent to soft tissue in accordance with at least some embodiments;

FIG. 7 illustrates a side view of a terminus of a suture configurationpassed retrograde through soft tissue in accordance with at least someembodiments;

FIG. 7A illustrates a suturing device for use in deploying the sutureconfiguration described herein in accordance with at least someembodiments;

FIG. 8A illustrates a view of an interwoven suture configuration inaccordance with at least some embodiments;

FIG. 8B illustrates a top view of a deployed interwoven sutureconfiguration in accordance with at least some embodiments;

FIG. 8C illustrates a top view of a deployed interwoven sutureconfiguration in accordance with at least some embodiments;

FIG. 8D illustrates a top view of a deployed interwoven sutureconfiguration in accordance with at least some embodiments;

FIG. 9 illustrates a top view of a interwoven suture “W” configurationin accordance with at least some embodiments; and

FIG. 10 illustrates a flow diagram of a procedure to secure connectivetissue to bone according to at least certain embodiments in the presentdisclosure.

DETAILED DESCRIPTION

The present invention provides an improved knotless suture apparatus forsuturing of soft tissue at a surgical repair site. In an exemplaryembodiment described herein, the apparatus is used to secure soft tissueto a bone structure, specifically the humeral bone of the humanshoulder. The length of suture is desirably looped through soft tissue,such as a rotator cuff tendon, to approximate and fix the soft tissuewith respect to the body cavity (e.g., bone structure). It should beunderstood, however, that the suture anchor apparatus may be utilized tosecure a length of suture to body cavities other than in a bonestructure, and may even be used to anchor the suture outside of a bodycavity, merely to a predetermined location within the body. In thisregard, the preferred apparatus includes an interwoven sutureconfiguration that may be variably arranged and adjusted freely and thenanchored or secured without knots.

A traditional knotted double row, transosseous equivalent repair isshown in FIGS. 1 (side view) and 2 (top view). Anchors A and C (medial)and B and D (lateral) are disposed beneath the tom tendon 100 andimplanted into the supporting bone 102. Sutures are attached to theseanchors, passed upward through the tendon. Knots 104 are tied in eachsuture above the corresponding medial anchor. These knots supply medialcompression. The sutures are then drawn to lateral implants B to supplyadditional compression over the length of the tissue. Advantageously,the knots supply a degree of medial compression even if the connectionto the lateral implant fails. Unfortunately, this benefit is realizedusing knots and therefore produces all of the drawbacks associated withknots.

A current version of a knotless double row, transosseous equivalentrepair is shown in FIGS. 3 (side view) and 4 (top view). The suture isthen drawn across the tissue and attached to anchors. Advantageously,this technique omits knots. Unfortunately, due to the absence of knots,this configuration only provides pressure at the medial implants if thelateral connection remains intact. If the connection to the lateralimplant fails, the entire repair fails.

The present disclosure pertains to a novel suture that permits singleand double row repair to be performed without using knots. The presentlydescribed suture configuration enables the true knotless double rowtransosseous technique to be performed arthroscopically by providing ajoined, double armed suture system with two independent suture strandsor limbs on both the medial and lateral sides that may be secured inknotless fashion. Such a suture system further facilitates soft tissuerepair by establishing an adjustable suture bridge for optimaltissue-bone footprint reestablishment in the area adjacent the joinedsuture junction. In certain embodiments, two lengths of suture areinterwoven over a predetermined length, such that the predeterminedlength of combined sutures forms a joined suture connection portion ofthe interwoven suture combination referred to by the applicant herein asa “belt.” FIG. 5A illustrates a first suture 202 and a second suture204. In step 200, suture 204 is passed through suture 202. In oneembodiment, suture 202 is a braided suture to facilitate thisinterweaving step, such that at one discrete location the braids ofsuture 202 are slightly separated to allow suture 204 to be interwoventhrough the separated braids of suture 202. Step 200 produces suture 206which is characterized by a single instance of interweaving suture 204into suture 202. In step 208, suture 204 is again passed through suture202 at a second location where, for example, the braids of suture 202are slightly separated, to produce suture system 210. This secondlocation of interweaving suture 204 through suture 202 establishes“belt” 212 which has a length L. The precise dimension or magnitude of Lcan be controlled by either repeating step 208 multiple times (i.e., byrepeating the interweaving step to create multiple locations or pointsof insertion and interweaving of suture 204 into suture 202) or bysimply increasing the distance between the two points of insertion 214and 216.

It is contemplated that one distinct length of suture need notcompletely penetrate the other to be interwoven. The first suture can bepartially inserted into the core of the second suture and reemerge onthe same side before the first suture is completely penetrated. In thismanner, the suture combination may be described as a “chromosome” typeconnection, where each length of suture touches the other and isconnected or attached at a common point, either by interweaving one ofthe lengths of suture into a portion of the other or by some similarmanner of joined connection between each respective length of suturewithout the need for knot tying. Additionally, a joined suture system iscontemplated where one of the lengths of suture has a smaller diameterthan the second length of suture, such that the smaller diameter suturemay slide inside a hollow portion of the second, larger diameter sutureto thereby facilitate an interwoven connection between the two. Thefirst suture can also be otherwise stitched to the second suture.Alternatively or additionally, two sutures can be connected by passingeach adjacently through a hollow band. Similarly to the beltconfiguration, the hollow band may be a desired length, dimension, ormagnitude. Another method for forming the belt is to use a suture suchas suture 500 of FIG. 5B in conjunction with suture 502. Suture 500includes one or more rings 504. To form a combined suture systemaccording to these embodiments, suture 502 is passed through rings 504of suture 500. The width of the rings defines the width of the belt.Generally, the belt may be from about 1 mm to about 15 mm in length. Inanother embodiment, the belt may be from about 5 mm to about 12 mm inlength.

Referring to FIG. 6, the terminus 300 of suture system 210 is passedthrough the soft tissue 100 downward, or retrograde, from top of thetissue to bottom in the direction of arrow 304, and then attached toanchor 302. In one embodiment, anchor 302 is a knotless suture anchor.This is a stark contrast with present surgical techniques which utilizean anchor that includes suture 308 which is passed upwards, oranterograde, from bottom of the tissue to top in the direction of arrow310, as illustrated in FIG. 7. In this technique, terminus 312 is latertied to the corresponding end of the same suture. In order to facilitateretrograde passing of the joined suture system presently describedherein, the modified use of a suture passing device such as theFirstPass® device (described in U.S. Patent Application Publication No.2011/0118760 and incorporated by reference herein) in conjunction withthe combined suture system described herein is contemplated. Referringnow to FIG. 7A, a suturing device 700 is inserted through a trocarcannula until jaws 702, 704 reach the tissue to be treated. In order tofacilitate retrograde passing of the combined suture system, suturingdevice 700 is inserted with the handle oriented up so that upper jaw 704is beneath the tissue and lower jaw 702 is above the tissue. Soft tissue100 is introduced into the space between the upper jaw 704 and the lowerjaw 702, and device 700 is actuated so that upper jaw 704 may clamp orgrasp the soft tissue 100 and immobilize it between the upper jaw 704and the lower jaw 702.

With the position of the soft tissue 100 grasped between jaws 702, 704and within the tissue receiving area 750 device 700 deemed satisfactory,needle 710 may be deployed to not only penetrate the top side of thesoft tissue, but to also capture and pass the combined suture systemthrough the soft tissue. In order to configure the combined suturesystem for retrograde passing through the soft tissue using device 700,at least one of the suture terminus 300 (see FIG. 6) or suture limbs(i.e., see FIG. 8A and suture system 210 with suture limbs 202A-B or204C-D) of a combined suture system is positioned within the sutureretaining area of device 700. In other contemplated embodiments, morethan one suture terminus or suture limb of a combined suture system maybe engaged by a needle 710 of device 700 and subsequently passed in aretrograde fashion through soft tissue 100. In the fully extendedposition of needle 710, the selected length of suture 300 that has beendrawn through soft tissue 100 forms a suture portion 320 which protrudesfrom the soft tissue and is disposed below upper jaw 704. In certainembodiments, suture portion 320 may form a looped configuration forlater manipulation to a bone anchor.

FIG. 8A depicts a combined suture system 210 according to certainembodiments with an “X” or “chromosome” configuration. Suture system 210has a first suture 202 and a second suture 204 with four separate suturelimbs (202A-B and 204C-D) and is further characterized by belt 212 wherethe individual lengths of suture are joined. Depending on the preciseinterweaving pattern, a given length of suture can provide any two ofthese limbs. Referring to FIGS. 8A and 8B, one repair technique usingsuture system 210 involves passing limb 202A down through soft tissue100. Limb 202B is similarly passed down through the tissue at some smalldistance from limb 202A. These limbs 202A, 202B are then each insertedinto a medially placed knotless anchor/implant A, such as the Opus®Magnum® 2 implant, Magnum X implant, or SpeedScrew® implant. As tensionis applied to suture system 210 and the limbs 202A and 202B are drawninto the implant A, the belt 212 of the suture begins to compress thetissue medially whereas belt 212 defines the length of the mattressportion of the stitch on the superior (bursal side) aspect of thetissue. As described above, the length L of belt 212 is selectable toaccommodate the repair construct desired by the practitioner, whereinfor example a greater length L may be desirable to increase thecompression footprint applied by belt 212 to the adjacent soft tissue. Asimilar procedure is repeated for implant C, where the belt 212 on asecond suture system 210 compresses the tissue at the insertion point ofthe suture limbs into the anchor. After two suture systems 210 have beenset into medial implants A and C, respectively, limbs 204C and 204D ofeach suture are spanned out and inserted into laterally placed knotlessimplants B and D (see FIG. 8B) and then appropriated tensioned andsecured. It should be noted that the span of limbs 204C and 204Dlaterally across the soft tissue 100 also serves to compress the tissueto the underlying bone structure in an effort to restore the anatomicalfootprint of the damaged tissue with respect to the bone.

Referring now to FIG. 8C, in certain other embodiments, a practitionermay, after securing medial limbs 204A, 204B into a lateral implant A andforming a belt 212, span one lateral limb 204C of a suture system 210from a medial implant into one lateral implant, both implants disposedgenerally anteriorly with regard to the patient's anatomical midline(e.g. A to B) followed by spanning a second lateral limb 204D from thesame medial implant to a different lateral implant, the second lateralimplant disposed more posteriorly in comparison to the first lateralimplant (e.g. A to D). Similarly, a second suture system 210 may be usedin conjunction after securing the two medial limbs to the medial implantand forming a belt 212 to span one lateral limb from a second medialimplant into the second lateral implant (e.g. C to D) followed byspanning a second lateral limb from the same medial implant to the firstlateral implant (e.g. C to B). In particular, this configuration hascriss-crossing suture limbs over the top of the rotator cuff potentiallyincreasing anatomical footprint compression of the soft tissue to theunderlying bone structure. The repair provides medial row compressionand fixation without the need for knots. Furthermore, medial rowfixation is independent of the lateral row as a function of tissuesecurement in the vicinity of belt 212. In the event of a partialfailure, the width of belt 212 provides a downward force that helps holdthe tissue against the bone at least in the area of the medial implant.

FIG. 8D depicts another configuration where the two medial limbs (202Aand 202B) are each attached to two different medial implants (A and C).The belt 212 is disposed between these two implants. The remaininglateral limbs (204C and 204D) are attached to two lateral implants B andD. In this configuration, belt 212 spans between the two medial implantsthereby providing medial row compression and fixation across a broaderfootprint. Additionally, this configuration ideally requires only onesuture system 210, thereby allowing the practitioner to limit theexercise of suture passing to two instances.

In another contemplated embodiment, not shown, more than two strands areinterwoven into a single belt position. For example, three sutures maybe interwoven at a single belt thereby producing a suture with six limbs(e.g., three medial suture limbs and three lateral suture limbs) and onebelt.

Referring now to FIG. 9, a suture system 900 with a “W” configuration isillustrated. Suture system 900 is similar to suture system 210 except inthat one of the sutures 902 has a third suture 904 woven into it atpoint 906, thereby establishing a second belt 914. First suture 902 isconnected to second suture 908 at point 910 to establish belt 912. Firstsuture 902 is also connected to third suture at point 906 to establishbelt 914. The second suture 908 and third suture 904 are not directlyconnected to one another. The W is formed by the two limbs (905A, 905B)of suture 904 and the two limbs (909A, 909B) of suture 908. The secondbelt is useful for spanning the gap between adjacent medial implants(e.g. implants A and C of FIG. 8D). Additionally, the limbs 903A, 903Bof suture 902 are each secured to medial row implants (i.e., implants Aand C) where the lateral row limbs are secured to lateral row implants(e.g., limbs 909A, 909B to implant B, limbs 905A, 905B to implant D).

Various materials may be used to form the suture system according to theembodiments described herein. For example, a number two high-strengthpolyethylene absorbable suture may be used. Other suitable suturematerials, both absorbable and non-absorbable, are known in the art andare contemplated for use with the present invention. Polyester,polyglycolic acid, polyurethane and other synthetic polymer sutures arewell known. The suture could be traditional-type high strength suturesor flat-based tape type sutures.

Various methods for forming the present sutures are contemplated. Forexample, the suture may be interwoven by the surgeon during surgery byinterweaving the two sutures during the operation. Alternatively, thesuture may be similarly interwoven prior to the operation. The suturemay also be manufactured in an X configuration. For example, a braidedsuture may be partially unwoven at its ends to produce the Xconfiguration.

In another embodiment, the invention pertains to a method of performingsoft tissue reattachment to bone. Referring to FIG. 10, the methodbegins with step 1000 in which a knotless interwoven suture, such assuture system 210, is provided that has at least four limbs and at leastone belt. In step 1002 at least two of these limbs are passed downward,through soft tissue. A suture shuttle may be used to pass the interwovensuture through the soft tissue. In step 1004 at least two knotlessanchors (one medial, one lateral) are implanted into bone. In oneembodiment, at least four anchors are implanted and the repair isperformed in the manner of a double row repair technique. The implantsare disposed under or adjacent tom soft tissue. In step 1006 two limbsof suture are attached to one anchor and at least one limb of the sutureto a second anchor. In step 1008 the limbs of the suture are tensionedacross the top surface of the soft tissue to cause its bottom surface torest securely against the bone. The suture limbs are tightened such thatthe belt is disposed above a corresponding anchor. The tensioning ofstep 1008 is dialed by means of the knotless lateral anchors.

While preferred embodiments of this invention have been shown anddescribed, modifications thereof can be made by one skilled in the artwithout departing from the scope or teaching herein. The embodimentsdescribed herein are exemplary only and are not limiting. Because manyvarying and different embodiments may be made within the scope of thepresent teachings, including equivalent structures or materialshereafter thought of, and because many modifications may be made in theembodiments herein detailed in accordance with the descriptiverequirements of the law, it is to be understood that the details hereinare to be interpreted as illustrative and not in a limiting sense.

The invention claimed is:
 1. A suture system for use arthroscopicallyconsisting of: a first and second suture, each of the first and secondsuture having two suture limbs such that the first and second sutureform four suture limbs; wherein at least one of the four limbsterminates in a needleless terminus, wherein the at least one needlelessterminus is operable to be engaged by a needle of a suture passinginstrument so as to pass the at least one needless terminus andassociated suture limb through soft tissue; wherein a portion of thefirst and second sutures are at least partially joined together to forma single suture junction, the single suture junction having a length andwherein the single suture junction is formed by partially inserting thefirst suture through a wall of the second suture into and along a coreof the second suture, and then re-emerging through a wall of the secondsuture; and wherein the first suture is completely contained within thesecond suture for the length of the single suture junction; and whereinthe four suture limbs extend away from each other defining the singlesuture junction length, and wherein two of the suture limbs areconfigured to extend from the single suture junction and be coupled to afirst fixation device, located within bone and under the soft tissue andthe other two suture limbs are configured to extend from the singlesuture junction and be coupled to a second fixation device locatedwithin bone and adjacent to, but not under, the soft tissue, each of thefour limbs configured to span the soft tissue from the suture junctionto one of the fixation devices and compress the soft tissue to bone; andwherein the entire length of the single suture junction is configured toabut the soft tissue so as to define a compression footprint on the softtissue and compress the soft tissue against the bone, directly under thefootprint.
 2. The suture system of claim 1, wherein the first suture andthe second suture are each formed of a plurality of braided fibers.
 3. Asuture system for use arthroscopically consisting of: a first and secondsuture, the first and second sutures each having two suture limbs suchthat the first and second sutures form four suture limbs; a suturepassing device having a needle configured to engage at least one suturelimb with a needleless terminus and pass the limb and terminus throughsoft tissue; wherein a portion of the first and second sutures are atleast partially joined together to form a single suture junction, thesingle suture junction having a length and wherein the single suturejunction is formed by partially inserting the first suture into andalong an internal core of the second suture and then re-emerging andwherein the second suture has a continuous lumen except for gaps, thegaps being formed by the first suture only, as the first suture isinserted and re-emerged; and wherein the four suture limbs extend awayfrom each other defining the single suture junction length, and whereintwo of the suture limbs are configured to be coupled to a first fixationdevice located within bone and under the soft tissue and the other twosuture limbs are configured to be coupled to a second fixation devicelocated within bone and adjacent to, but not under, the soft tissue,each of the four limbs configured to span the tissue from the suturejunction to either the first fixation device or the second fixationdevice and compress the tissue to bone; and wherein the entire length ofthe single suture junction is configured to abut a target tissue so asto define a compression footprint on the target tissue and compress thetarget tissue against the bone, directly under the footprint.
 4. Thesuture system of claim 3, wherein the gaps are formed by slightlyseparating the plurality of braided fibers of the second suture.
 5. Asuture system for single or double row rotator cuff repair consistingof: a first and second suture joined together at a single suturejunction, wherein the first suture is completely contained within thesecond suture for an entire length of the single suture junction, andwherein each of the first and second sutures have two suture limbs suchthat the first and second sutures form four suture limbs; and whereineach of the four suture limbs are configured to span a rotator cufftendon either from the single suture junction to a first fixation devicelocated within bone and under the tendon or from the single suturejunction to a second fixation device located within bone and adjacentto, but not under, the tendon or from the suture junction to a thirdfixation device located adjacent the second fixation device and compressthe tendon to bone.
 6. A suture system for use arthroscopicallyconsisting of: a first and second suture, the first and second sutureseach having two suture limbs such that the first and second sutures formfour suture limbs; wherein a portion of the first and second sutures areat least partially joined together to form a single suture belt, thesingle suture belt having a length and wherein the single suture belt isformed by partially inserting the first suture through a wall of thesecond suture into and along a core of the second suture, and thenre-emerging through a wall of the second suture; and wherein the firstsuture is completely contained within the second suture for the lengthof the single suture belt; and wherein the four suture limbs extend awayfrom each other defining the single suture belt length, and wherein twoof the suture limbs are configured to extend from the single suture beltand be coupled to a first fixation device, located within bone and undera soft tissue and the other two suture limbs are configured to extendfrom the single suture belt and be coupled to a second fixation devicelocated within bone and adjacent to, but not under, the soft tissue,each of the four limbs configured to span the soft tissue from thesuture belt to one of the fixation devices and compress the soft tissueto bone; and wherein an entire length of the single suture belt isconfigured to abut the soft tissue so as to define a compressionfootprint on the soft tissue and compress the soft tissue against thebone, directly under the footprint.